OneTouch Ultra Plus Flex Blood Glucose Monitoring System— 510(k) K151611

Substantially Equivalent

Lifescan Europe

FDA 510(k) clearance K151611 for OneTouch Ultra Plus Flex Blood Glucose Monitoring System, Substantially Equivalent on 2015-12-14. Applicant: Lifescan Europe.

Clearance details

Applicant: Lifescan Europe
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2015-06-15
Decision date: 2015-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zug, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.